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Bharat Biotech’s coronavirus vaccine Covaxin has obtained approval for carrying out Phase III trials on October 22, reports suggest.
The approvals were reportedly given after analyzing data from Phase I and II and animal challenge study.
Phase III is very likely to start next month, Business Today reported. The report stated a professional committee met on October 20 to give its nod to Phase III trials and indicated some’minor amendments’ from the protocol.
Bharat Biotech had implemented to the Drugs Controller General of India (DCGI) seeking permission for its crucial Stage III of trials on October 2, NDTV reported.
In its application, the firm said the study would cover over 28,500 subjects, aged 18 years and over. The analysis would be conducted at 19 sites in 10 states throughout the country, the report said.
Phase I of Covaxin’s clinical trial included 375 volunteers. Interim data from Phase I’ve not been made public yet.
Two doses of this Covaxin vaccine candidate are to be administered with a gap of 14 days between them. Bruker Corporation today announced the release of the Vutara VXL Super-Resolution Fluorescence Microscope for nanoscale biological imaging. The new system opens an affordable and easy-to-use path for both core facilities and individual investigators to enter the world of super-resolution imaging by integrating Bruker’s industry-leading single-molecule localization (SML) technology in a compact system with compact footprint.
